CINGW

Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations and, in these circumstances, the market price of our securities would likely decline.
We are not currently profitable, and we may never achieve or sustain profitability. ● We need to raise significant additional capital to continue operations, including to complete the development and commercialization efforts for CTx-1301.
If we are unable to raise additional capital, we could be required to seek bankruptcy protection or other alternatives that would likely result in our securityholders losing some or all of their investment in us. ● The Note Purchase Agreement and Note issued in November 2025 contain restrictive covenants and adjustments in the event of a default that may limit our operating flexibility and affect our business operations and financial condition. ● If we fail to maintain compliance with the continued listing requirements of Nasdaq, our common stock and/or warrants may be delisted and the price of our common stock and/or warrants and our ability to access the capital markets could be negatively impacted. ● We are dependent primarily on the successful development and commercialization of our product candidates, CTx-1301 and CTx-1302 for the treatment of ADHD and CTx-2103 for the treatment of anxiety, which are in either product/early clinical development (CTx-2103), late development (CTx-1301) or planned for future product development (CTx-1302) and are not yet approved.
We cannot give any assurance that we will receive regulatory approval for such product candidates or any other product candidates, which is necessary before they can be commercialized. ● Even if we obtain regulatory approval for one or more of our product candidates, such approval may be limited, and we will be subject to stringent, ongoing government regulation.
If these third parties fail to perform as expected or to comply with legal and regulatory requirements, our ability to commercialize our product candidates will be significantly impacted and we may be subject to regulatory sanctions. ● If we are not able to maintain or establish collaborations, we may have to alter our development and commercialization plans. ● We will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in executing our growth strategy and managing any growth. ● Our research and development is focused on discovering and developing product candidates, which may not make it to the market. ● We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks. ● If our intellectual property related to our products or product candidates is not adequate, we may not be able to compete effectively in our market. ● An active trading market for our securities may not be sustained.
In particular, potential investors should consider that we cannot assure you that we will be able to, among other things: ● successfully implement or execute our business plan, and we cannot assure you that our business plan is sound; ● secure approval of CTx-1301 or any of our product candidates; ● successfully complete product development/formulation, and clinical trials for CTx-1301, CTx-1302, and/or CTx-2103 as well as for the marketing of any or all products; ● successfully manufacture or have manufactured clinical product and establish commercial drug supply in light of the manufacturing delays we experienced prior to October 2022 with respect to the clinical supply of CTx-1301 at our former contract manufacturing organization (“CDMO”) and the Form 483 issued by the FDA to our current CDMO in February 2026 as a result of the FDA’s pre-approval inspection; ● raise sufficient funds in the capital markets or otherwise to effectuate our business plan; ● secure adequate intellectual property protection for our products; ● attract and retain an experienced management and advisory team; ● secure acceptance of our drug candidates in the medical community and with third-party payors and consumers; ● launch commercial sales of our drug candidates, whether alone or in partnership with others; ● comply with post-marketing regulatory requirements; and ● utilize the funds that we do have and/or raise in the future to efficiently execute our business strategy.
We have never generated revenue from operations and are currently operating at a loss and expect our operating costs will increase significantly as we incur costs related to formulation/manufacturing development, the clinical trials for our drug candidates and operating as a public company and, if we are successful in obtaining regulatory approval to market one or more of our product candidates, the marketing and commercialization of such approved product(s).
We expect to incur expenses without corresponding revenues unless and until we are able to obtain regulatory approval and successfully commercialize CTx-1301.
Even if we obtain regulatory approval for CTx-1301, development expenses will continue to increase for any future assets.
As we continue to develop CTx-1301, seek marketing approval and conduct pre-commercialization activities, we will continue to incur substantial costs.
We have incurred recurring losses since inception and had an accumulated deficit of approximately $132.4 million as of December 31, 2025.
Even if we are successful in obtaining regulatory approval for CTx-1301 or one or more of our other drug candidates, our ability to generate revenue will still be dependent on a number of factors outside of our control, including, the size of the addressable market, the label for which approval is granted, the accepted price for the product, and/or the ability to get and maintain adequate coverage and reimbursement.
See “If our drug candidates for which we obtain regulatory approval do not achieve broad acceptance from physicians, patients and third-party payors, we may be unable to generate significant revenues, if any” below.
We will continue to expend substantial cash resources for the foreseeable future for the clinical development of our product candidates and development of any other indications and product candidates we may choose to pursue, and, if we are successful in obtaining regulatory approval to market one or more of our product candidates, the marketing and commercialization of such approved product(s).
If one or more of our product candidates are approved by the FDA, these expenditures will also include [__].
We depend heavily on the success of CTx-1301.
If we are unable to secure approval of CTx-1301, we will never be able to generate revenues from CTx-1301, and our ability to create stockholder value will be severely limited.
Our most advanced product candidate currently is CTx-1301, for which we submitted a NDA with the FDA in July 2025.
We do not currently generate revenues from any FDA approved drug products and our other product candidates are in the early stages of development.
Completing the process of obtaining FDA approval of the pending NDA for CTx-1301 still involves substantial risk.
We completed the NDA submission to the FDA in July 2025.
On October 9, 2025, the NDA submission was accepted by the FDA and a PDUFA target action date of May 31, 2026 was assigned.
To date, the FDA has made several information requests, primarily related to CMC, as it reviews our Precision Timed Release™ Platform, the first tri-modal, pulsatile capable tablet delivery system.
We have been engaged with and responded to all information requests from the FDA received to date.
In February 2026, the FDA conducted a pre-approval inspection of our CDMO’s facility used to manufacture CTx-1301.
This facility was issued a Form 483 by the FDA at the conclusion of the inspection with three observations.
Two observations were related to the facility, and one observation was specific to CTx-1301.
Our CDMO is working on responses to these observations, with our input where relevant.
Our efforts (and those of our CDMO) to develop, make and win approval for CTx-1301 continue to be subject to inspection and approval by the FDA and other factors outside of our control, and there remains a risk that the required FDA approvals of CTx-1301 and/or our CDMO’s facility used to manufacture CTx-1301 could be further delayed or not obtained.
There can be no assurance that approval of CTx-1301 will occur on the previously expected timeline or that it will occur at all, which would significantly harm our business, results of operations and prospects.
We will need to raise significant additional capital to continue to support our planned development and commercialization activities.
We believe that our cash on hand will satisfy our capital needs late into the fourth quarter of 2026 under our current business plan.
The amount and timing of our future funding requirements will depend on many factors, including: ● the timing, rate of progress and cost of any clinical trials and other manufacturing/product development activities for our current and any future product candidates that we develop, in-license or acquire; ● the results of the clinical trials for our product candidates in the United States and any foreign countries; ● the timing of, and the costs involved in, FDA approval and any foreign regulatory approval of our product candidates, if at all; ● the number and characteristics of any additional future product candidates we develop or acquire; ● our ability to establish and maintain strategic partnerships, licensing, co-promotion or other arrangements and the terms and timing of such arrangements; ● the cost of commercialization activities if our current or any future product candidates are approved for sale, including manufacturing, marketing, sales and distribution costs; ● the degree and rate of market acceptance of any approved products; ● costs under our third-party manufacturing and supply arrangements for our current and any future product candidates and any products we commercialize; ● costs and timing of completion of any additional outsourced commercial manufacturing or supply arrangements that we may establish; ● the willingness of our third-party service providers to continue to provide services based on our limited liquidity and those service providers not requiring pre-payment for services; ● costs of preparing, filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights associated with our product candidates; ● costs associated with prosecuting or defending any litigation that we are or may become involved in and any damages payable by us that result from such litigation; ● costs associated with any product recall that could occur; ● costs of operating as a public company; ● the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing products or treatments; ● costs associated with any acquisition or in-license of products and product candidates, technologies or businesses; ● personnel, facilities and equipment requirements; and ● continued compliance with the terms of the Note Purchase Agreement and Note issued by us in November 2025.
In November 2025, we issued the Note to Lender.
Pursuant to the Note Purchase Agreement, while the Note is outstanding, we will not enter into any arrangement that prohibits us from entering into a variable rate transaction with Lender or its affiliates, or from issuing our securities to Lender or its affiliates.
We are also prohibited from entering into a variable rate transaction while the Note is outstanding, subject to certain exceptions.
If we are unable to raise additional capital when required or on acceptable terms or if we are unable to enter into strategic collaborations for our product candidates, we may be required to further restrict our operations or obtain funds by entering into agreements on unattractive terms, which would likely have a material adverse effect on our business, stock price and our relationships with third parties with whom we have business relationships, at least until additional funding is obtained.
In addition, if we are unable to secure sufficient capital to fund our operations, we may have to enter into strategic collaborations that could require us to share commercial rights to our product candidates with third parties in ways that we currently do not intend or on terms that may not be favorable to us or our securityholders.
The note purchase agreement and note issued by us in November 2025 contain restrictive covenants and adjustments in the event we default on the Note that may limit our operating flexibility and impact our operations.
In November 2025, we entered into a Note Purchase Agreement with Avondale Capital, LLC, or Lender, pursuant to which we issued and sold to Lender an unsecured promissory note, or Note, in the amount of $6,570,000.

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Gone since FY2024

Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations in these circumstances, the market price of our securities would likely decline.
We are not currently profitable, and we may never achieve or sustain profitability. ● We need to raise significant additional capital to continue operations, including to complete the development and commercialization efforts for CTx-1301, CTx-1302 and/or CTx-2103.
If we are unable to raise additional capital, we could be required to seek bankruptcy protection or other alternatives that would likely result in our securityholders losing some or all of their investment in us. ● The Note Purchase Agreement and Note issued in December 2024 contain restrictive covenants and adjustments in the event of a default that may limit our operating flexibility and affect our business operations and financial condition. ● If we fail to regain and maintain compliance with the continued listing requirements of Nasdaq, our common stock and/or warrants may be delisted and the price of our common stock and/or warrants and our ability to access the capital markets could be negatively impacted. ● We are dependent primarily on the successful development and commercialization of our product candidates, CTx-1301 and CTx-1302 for the treatment of ADHD and CTx-2103 for the treatment of anxiety, which are in either in product/early clinical development (CTx-2103), clinical development (CTx-1301) or planned for future product development (CTx-1302) and are not yet approved.
We cannot give any assurance that we will receive regulatory approval for such product candidates or any other product candidates, which is necessary before they can be commercialized. ● Even if we obtain regulatory approval for CTx-1301, CTx-1302 and CTx-2103, such approval may be limited, and we will be subject to stringent, ongoing government regulation.
If these third parties fail to perform as expected or to comply with legal and regulatory requirements, our ability to commercialize CTx-1301, CTx-1302, and/or CTx-2103 will be significantly impacted and we may be subject to regulatory sanctions. ● If we are not able to maintain or establish collaborations, we may have to alter our development and commercialization plans. ● We will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in executing our growth strategy and managing any growth. ● Our research and development is focused on discovering and developing product candidates, which may not make it to the market. ● We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks. ● If our intellectual property related to our products or product candidates is not adequate, we may not be able to compete effectively in our market. ● An active trading market for our securities may not be sustained.
In particular, potential investors should consider that we cannot assure you that we will be able to, among other things: ● successfully implement or execute our business plan, and we cannot assure you that our business plan is sound; ● successfully complete product development/formulation, and clinical trials for CTx-1301, CTx-1302, and/or CTx-2103 as well as for the marketing of any or all products; ● successfully manufacture or have manufactured clinical product and establish commercial drug supply in light of the manufacturing delays we experienced prior to October 2022 with respect to the clinical supply of CTx-1301 at our former contract manufacturing organization (“CMO”); ● raise sufficient funds in the capital markets or otherwise to effectuate our business plan; ● secure adequate intellectual property protection for our products; ● attract and retain an experienced management and advisory team in light of the departure of executive officers and other employees in December 2023; ● secure acceptance of our drug candidates in the medical community and with third-party payors and consumers; ● secure a partnership for CTx-1301 or our other product candidates; ● launch commercial sales of our drug candidates, whether alone or in partnership with others; ● comply with post-marketing regulatory requirements; and ● utilize the funds that we do have and/or raise in the future to efficiently execute our business strategy.
We have never generated revenue from operations and are currently operating at a loss and expect our operating costs will increase significantly as we incur costs related to formulation/manufacturing development, the clinical trials for our drug candidates and operating as a public company.
We expect to incur expenses without corresponding revenues unless and until we are able to obtain regulatory approval and successfully commercialize our product candidates, CTx-1301, CTx-1302 and CTx-2103.
Even if we obtain regulatory approval for CTx-1301, CTx-1302 and/or CTx-2103, development expenses will continue to increase for any future assets.
As we are performing the data consolidation and analytical activities for CTx-1301 Phase 3 clinical trials in pursuit of FDA approval, we will continue to incur costs.
We have incurred recurring losses since inception and had an accumulated deficit of approximately $108.5 million as of December 31, 2024.
We will continue to expend substantial cash resources for the foreseeable future for the clinical development of our product candidates and development of any other indications and product candidates we may choose to pursue.
We will need to raise significant additional capital to continue operations and continue to support our planned development and commercialization activities.
We believe that our cash on hand will satisfy our capital needs into the fourth quarter of 2025 under our current business plan.
The amount and timing of our future funding requirements will depend on many factors, including: ● the timing, rate of progress and cost of any clinical trials and other manufacturing/product development activities for our current and any future product candidates that we develop, in-license or acquire; ● the results of the clinical trials for our product candidates in the United States and any foreign countries; ● the timing of, and the costs involved in, FDA approval and any foreign regulatory approval of our product candidates, if at all; ● the number and characteristics of any additional future product candidates we develop or acquire; ● our ability to establish and maintain strategic partnerships, licensing, co-promotion or other arrangements and the terms and timing of such arrangements; ● the cost of commercialization activities if our current or any future product candidates are approved for sale, including manufacturing, marketing, sales and distribution costs; ● the degree and rate of market acceptance of any approved products; ● costs under our third-party manufacturing and supply arrangements for our current and any future product candidates and any products we commercialize; ● costs and timing of completion of any additional outsourced commercial manufacturing or supply arrangements that we may establish; ● the willingness of our third-party service providers to continue to provide services based on our limited liquidity and those service providers not requiring pre-payment for services; ● costs of preparing, filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights associated with our product candidates; ● costs associated with prosecuting or defending any litigation that we are or may become involved in and any damages payable by us that result from such litigation; ● costs associated with any product recall that could occur; ● costs of operating as a public company; ● the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing products or treatments; ● costs associated with any acquisition or in-license of products and product candidates, technologies or businesses; ● personnel, facilities and equipment requirements; and ● continued compliance with the terms of the Note Purchase Agreement and Note issued by us in December 2024.
In December 2024, we issued the Note to Lender.
Pursuant to the Note Purchase Agreement, while the Note is outstanding, we will not enter into any arrangement that prohibits us from entering into a variable rate transaction until July 1, 2025, subject to certain exceptions.
If we are unable to raise additional capital when required or on acceptable terms or if we are unable to enter into strategic collaborations for CTx-1301, CTx-1302, and/or CTx-2103, we may be required to further restrict our operations or obtain funds by entering into agreements on unattractive terms, which would likely have a material adverse effect on our business, stock price and our relationships with third parties with whom we have business relationships, at least until additional funding is obtained.
In addition, if we are unable to secure sufficient capital to fund our operations, we may have to enter into strategic collaborations that could require us to share commercial rights to CTx-1301, CTx-1302, and/or CTx-2103 with third parties in ways that we currently do not intend or on terms that may not be favorable to us or our securityholders.
The Note Purchase Agreement and Note issued by us in December 2024 contain restrictive covenants and adjustments in the event we default on the Note that may limit our operating flexibility and impact our operations.
On December 20, 2024, we entered into a Note Purchase Agreement with Streeterville Capital, LLC, or Lender, pursuant to which we issued and sold to Lender an unsecured promissory note, or Note, in the amount of $5,480,000.
If we are unable to obtain Lender’s consent prior to issuing any debt or certain equity securities, such issuance may be a breach of the Note Purchase Agreement, and we may be obligated to indemnify Lender for loss or damage arising as a result of any breach or alleged breach by us of the Note Purchase Agreement, which may affect our business operations and financial condition.
In addition, from time to time, beginning on July 2, 2025, Lender may redeem a portion of the Note, not to exceed an amount of $550,000 per month.
Our failure to pay such redemptions, when due, may result in defaults under our agreements with the Lender.
The report of our independent registered public accounting firm for the fiscal years ended December 31, 2024 and 2023 contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.
The report of our independent registered public accounting firm on our financial statements as of and for the years ended December 31, 2024 and December 31, 2023 includes an explanatory paragraph indicating that there is substantial doubt about our ability to continue as a going concern.
Risks Related to Development, Clinical Testing, Manufacturing and Regulatory Approval We depend heavily on the success of CTx-1301.
If we are unable to generate revenues from CTx-1301, our ability to create stockholder value will be limited.
Our most advanced product candidate currently is CTx-1301, for which we are anticipating to submit a NDA application with the FDA in mid-2025.
We do not generate revenues from any FDA approved drug products and our other product candidates are in the early stages of development.
We are dependent primarily on the successful development and commercialization of our product candidates, CTx-1301 and CTx-1302 for the treatment of ADHD and CTx-2103 for the treatment of anxiety, which are either in product/early clinical development (CTx-2103), clinical development (CTx-1301) or planned for future product development (CTx-1302) and are not yet approved.
Development will require the commitment of substantial financial resources, extensive product candidate development, and clinical trials.
Our product development efforts with respect to CTx-1301, CTx-1302 and/or CTx-2103 may fail for many reasons, including but not limited to: ● the failure of the product candidate in clinical studies; ● adverse patient reactions to the product candidate or indications of other safety concerns; ● insufficient clinical trial data to support the effectiveness or superiority of the product candidate; ● the inability to manufacture sufficient quantities of the product candidate for development or commercialization activities in a timely and cost-efficient manner; and ● changes in the regulatory environment, including pricing and reimbursement, that make development of a new product or of an existing product for a new indication no longer attractive.
We have not submitted a marketing application such as an NDA to the FDA or any similar application to any other regulatory authority in any jurisdiction.
For example, the FDA: ● could determine that we cannot rely on the 505(b)(2) regulatory approval pathway for CTx-1301, CTx-1302, CTx-2103 or any other product candidate that we may identify and develop; ● could determine that the information provided by us as part of an IND or NDA is inadequate, contains clinical deficiencies or otherwise fails to demonstrate safety and effectiveness of any of our product candidates for any indication; ● may not find the data from bioequivalence studies and/or clinical trials sufficient to support the submission of an NDA or to obtain marketing approval in the United States, including any findings that the safety risks outweigh clinical and other benefits of our product candidates; ● may require us to perform additional studies to demonstrate the safety, efficacy, pharmacokinetics, or other properties of our product candidates prior to approval, or require such studies as a condition of approval; ● may disagree with our clinical trial designs or our interpretation of data from product development manufacturing data, bioequivalence studies and/or clinical trials, or may change the requirements for approval even after it has reviewed and commented on the design for our trials; ● may determine that we inappropriately relied on a certain listed drug or drugs for our 505(b)(2) NDA or that approval of our applications for CTx-1301, CTx-1302, CTx-2103 or any other product candidate is blocked by patent or non-patent exclusivity of the listed drug or drugs; ● may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for the supply of the API used in our product candidates; ● may identify deficiencies in our own manufacturing processes or our proposed scale-up of the manufacturing processes or facilities for the production of our product candidates; ● may approve our product candidates for fewer or more limited indications than we request, or may grant approval contingent on the performance of costly post-approval clinical trials; ● may change its approval policies or adopt new regulations; or ● may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our product candidates.
The time and expense of the approval process, as well as the unpredictability of future clinical trial results and other contributing factors, may result in our failure to obtain regulatory approval to market, in the United States or other jurisdictions, CTx-1301, CTx-1302, CTx-2103, or any other drug candidates we are developing or may seek to develop in the future, which would significantly harm our business, results of operations and prospects.
In such case, we may also not have the resources to conduct new clinical trials and/or we may determine that further clinical development of any such drug candidate is not justified and may discontinue any such programs.
In late 2023, we announced a change in the clinical development plan for CTx-1301 based on feedback from FDA, and accordingly stopped enrollment in two Phase 3 trials of CTx-1301 and are performing the data consolidation and analytical activities for these trials in pursuit of NDA submission expected in mid-2025.
Significant product manufacturing or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidates.
Although, we have stopped enrollment in the pivotal Phase 3 fixed-dose pediatric and adolescent safety and efficacy study of CTx-1301 and the Phase 3 pediatric dose-optimization onset and duration study of CTx-1301 and are performing the data consolidation and analytical activities for these trials in pursuit of NDA submission expected in mid-2025, we may have to restart and complete these and other trials in order to obtain approval.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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